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Johnson & Johnson pauses COVID-19 vaccine trial after volunteer falls ill

As the company has not revealed the details about the unexplained illness, it has decided to stop the study while doctors find out if the illness was caused because of the vaccine or if it was a coincidence.

Oct 13, 2020 11:04 IST
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Johnson & Johnson, a pharmaceutical company announced on October 12, 2020, that it decided to pause the advance clinical trial, ENSEMBLE, of one of its vaccine. The step was taken by the company after an unexplained illness was found in one of the volunteers of the clinical trial.

According to the statement released by the company, following the guidelines, the illness in the participant is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB), as well as the internal safety and clinical physicians of the company.

ENSEMBLE is the name of the study and the injection is being developed by the Janssen vaccine arm of Johnson & Johnson to fight the ongoing pandemic. The clinical trial by the company is also one of the biggest trials with 60,000 people.

Johnson & Johnson on the unexplained illness in participant:

While providing the clarification, the pharmaceutical company added that any form of adverse events such as accidents, illness, etc. even if they are serious, is expected in any form of a clinical study, especially if it involves a large number of participants.

The company also talked about its strong commitment to safety and added that al the clinical trials that have been carried out by the Janssen Pharmaceutical Company have prespecified guidelines which state that studies must be paused in case a serious adverse event (SAE) is noticed in relation to the vaccine so that all the medical information can be carefully reviewed.

Identifying the illness in the volunteer:

As the company has not revealed the details about the unexplained illness, it has decided to stop the study while doctors find out if the illness was caused because of the vaccine or if it was a coincidence. The idea behind the clinical trials of the vaccine is to explore the possible dangerous side effects of the vaccination.

The pharmaceutical company added that they are also learning more about the participant’s illness and it is essential to have all the facts before any information is shared.

Is the pause of clinical trial concerning?

Ashish Jha, the Dean of the Brown University School of Public Health has informed that the pause is not immediately concerning and it can be completely expected. He added that the trial by Johnson & Johnson is the biggest vaccine trial of 60,000 people, so few pauses can be naturally expected.

However, he further claimed that there is a difference between a regulatory hold and a study pause on a clinical trial. Study pause is in which dosing or recruitment is paused by the study sponsor. It is a standard component of a clinical trial protocol.

While appreciating the decision, Jha mentioned that the pause means that they want the vaccine to be safe and it is reassuring that the companies are acting responsibly.

Second phase three trial to be paused after AstraZeneca:

The pause of the Johnson & Johnson vaccine trial is the second phase three trial to be paused after the AstraZeneca vaccine trial in the United States.

However, as the trial has resumed there as well as in other countries, it still remains paused in the US as the US Food and Drug Administration investigates.

Johnson & Johnson COVID-19 vaccine trial: Background

Johnson & Johnson’s phase three trial of the COVID-19 vaccine started in September 2020. It is also one of the six COVID-19 vaccines which are being tested in the US and is also one of the four in the most advanced stage.

The vaccine by Johnson & Johnson requires only one dose which makes federal officials hope that the testing might be completed a bit faster than other vaccines, including those being made by Pfizer and Moderna.

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